Application 091525

Type: ANDA
Sponsor: NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	INJECTABLE;INJECTION	1MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091525-001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP		2013-02-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A091525-001	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091525-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2013-02-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091525-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091525-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091525-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091525-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091525-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091525-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091525-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091525-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091525-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091525-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091525-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091525-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091525-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091525-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091525-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091525-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091525-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091525-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091525-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091525-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091525-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091525-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091525-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091525-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091525-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091525-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091525-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091525-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091525-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091525-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091525-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091525-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091525-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091525-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091525-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091525-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091525-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091525-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091525-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091525-001	AP	1	`cb3db0bc1861…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benztropine Mesylate	BENZTROPINE MESYLATE	Navinta LLC	f92fbafa-314d-4449-831f-26108339e6b2	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091525 application number: ANDA091525 ndc (product): 68475-512
Benztropine Mesylate	BENZTROPINE MESYLATE	Zydus Pharmaceuticals USA Inc.	ecaeaadf-0847-4605-a205-a674f75f8bb2	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091525 application number: ANDA091525 ndc (product): 68382-860

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10858-011	benztropine mesylate	benztropine mesylate	Wintac Limited	ANDA	Current
68382-860	Benztropine Mesylate	Benztropine Mesylate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-860	Benztropine Mesylate	Benztropine Mesylate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68475-512	Benztropine Mesylate	Benztropine Mesylate	Navinta LLC	ANDA	Current
68475-512	Benztropine Mesylate	Benztropine Mesylate	Navinta LLC	ANDA	Current